תקציר
Responsible to ensure compliance to cGxP standards for products within area of responsibility (during development, transfer and commercialization) and product release.
Provide guidance, support and leadership to teams within area of responsibility. Might provide on shift support per business needs.
About the Role
Key Responsibilities：
- As per local regulatory requirement and global guidance/SOP to set up local documentation hierarchy, manage quality system. Oversight of Quality Operations. Set up training matrix and curriculums in 2025
- Validation Batch Record review; Validation protocols review; Deviation management; On site Quality monitoring. Support and oversight validation activities. Master Batch Record review and approval
- As site QP or delegation to release product, Initiate and maintain Site Master File
- Local supplier qualification and management
- Audit and Inspection preparation and readiness. Collaboration in GxP audits/inspections
- Function representative to be involved in global and/or local project if any.
- Actively support and promote talent exchange for the benefit of the individuals and organization. Ensure the consistency between career development processes and the business strategy. Ensure that associates are qualified for a GMP task prior to independent performance. Monitor overall training compliance for in-scope associates. Role model the culture aspiration of being Curious, Inspired and Un-bossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey
- Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the project. Guarantee the effectiveness of the Business Continuity Plan
- Being part of the project crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management). By delegation of the project Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on-call management system.
- Responsible for participating in initial training and retraining. HSE incidents reporting & action follow-up
Essential Requirements:
- 8-10 years’ experience in the field of Quality Assurance and Sterility Product Manufacturing in a pharmaceutical industry environment or equivalent
- Project management, Operations Management and Execution, People Leadership, Collaborating across boundaries, Functional Breadth, Project Management, Financial Management, Industry/ Business Exposure
- University degree in Pharmacy, Engineering, Chemistry, Biotechnology or equivalent
- Fluent (oral and written) in English; local language desired
- Collaboration; result-oriented
- Advanced communication skills; motivates colleagues and co-workers
- Leadership and change management, objective setting and performance management
Desirable Requirements:
- Knowledge of GMP Quality Assurance, Quality Control (QC) Testing and Manufacturing Process/Product Expertise
- Rich experience on audit and inspection preparation and management
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
